Image Md Restoring Lip Enhancer Spf15 Cream
NDC Package 60232-3537-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Image Md Restoring Lip Enhancer Spf15 (sunscreen) cream is helps prevent sunburn. This formulation utilizes a cream delivery system. Marketed by Swiss-american Cdmo, Llc, this product is identified by NDC 60232-3537 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
60232-3537-0
Package Description
15 g in 1 TUBE
Product Code
60232-3537
11-Digit Billing Format
60232353700

Clinical Specifications

Proprietary Name
Image Md Restoring Lip Enhancer Spf15
Non-Proprietary Name
Sunscreen
Substance Name
Avobenzone; Homosalate; Octisalate; Octocrylene
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Usage Information
Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Regulatory & Marketing

Labeler Name
Swiss-american Cdmo, Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-17-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 60232-3537-0 identifies a specific commercial package of 15 g in 1 tube of Image Md Restoring Lip Enhancer Spf15, a human over the counter drug labeled by Swiss-american Cdmo, Llc. This cream is formulated for topical use and contains avobenzone; homosalate; octisalate; octocrylene as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Swiss-american Cdmo, Llc on March 17, 2022. The current certification is valid through December 31, 2026.

How is this Swiss-american Cdmo, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60232353700. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
60232-3537-0
11-Digit CMS (5-4-2)
60232-3537-00

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.